DFC Studies

MASTER PROTOCOL

Open DFU Master Protocol
  • This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions. The platform study is designed to be flexible so that it is suitable for a wide range of studies relevant to individuals with open (active) DFUs. This platform study will enroll people with DFUs seen in an outpatient setting in diabetic foot and wound care clinics across a range of healthcare systems, including community settings and tertiary care hospitals, participating in the DFC. SABER is the DCC for this project and will provide project management, data management, software development, and statistical analysis.
  • STATUS: First subject enrolled June 29th, 2023. In enrollment and followup.
  • New ancillary applications are encouraged to leverage the DFC master protocol and infrastructure to test additional promising biomarkers. Please submit your applications to the following email address: DFC-Ancillary@umich.edu

CMYC

Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers – c-myc and phosphorylated glucocorticoid receptor

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound’s edge. An additional tissue specimen is collected at 4 weeks. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

Click here for more information on the cmyc Study.
Publications with more information regarding c-myc and pGR

TEWL

TRANS-EPIDERMAL WATER LOSS (TEWL) AS A PREDICTIVE MARKER FOR DIABETIC FOOT ULCER (DFU) RECURRENCE

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.

Click here for more information on the TEWL Study.

Biorepository

Adjunct collection of additional biorepository data from patients enrolled in DFC trials

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop, implement, and organize a biorepository program for the collection of biosamples and associated clinical data to inform and assist with future research endeavors. The Biorepository will guide the DFC activities for collection and storing biosamples and data from participants enrolled in current and future DFC studies. Participants will be asked to enroll at the time of DFC protocol 001 (c-myc), DFC protocol 002 (TEWL), and future DFC approved protocol enrollment. Participants will be informed of long-term archiving of biosamples in the NIDDK Central Repository (including de-identified data in the data repository) prior to enrollment in the biorepository study.

Publications with more information regarding biorepositories